510(k) K250215

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand by Cochlear — Product Code LXB

K250215 is an FDA 510(k) premarket notification submitted by Cochlear for the device "Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand". The FDA issued a decision of Substantially Equivalent on May 29, 2025. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302. Cochlear has at least 2 other 510(k) clearances on record.